Finexel

Basic Information

• Brand Name: Finexel
• Primary DI: 08800086000039
• Version / Model: Finexel
• Company Name: SNJ CO., LTD
• Labeler DUNS: 688224067
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-05-03
• Public Version: 1
• Public Version Date: 2023-05-11
• Public Version Status: New
• Public Device Record Key: bcab82bd-1f29-4e9c-a295-029a39e3dea1

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	878.4810	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64098	General/multiple surgical carbon dioxide laser system	A mains electricity (AC-powered) device assembly in which input energy is used to excite carbon dioxide (CO2) to emit a high-power laser beam intended to incise, excise, ablate, vaporize and coagulate soft tissues across multiple clinical specialties (e.g., dermatological, gynaecological, ENT) using both ablative and non-ablative lasing; it is not dedicated to a specific specialty. It typically includes a light source, delivery/positioning device(s), and controls/foot-switch. It does not include a therapeutic solid-state or diode laser.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08800086000039	GS1

Premarket Submissions

Submission Number	Supplement Number
K213557	000